Lakewood-Amedex Biotherapeutics (LABT) FDA Approvals $1.81 +0.03 (+1.85%) As of 11:45 AM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsNews and TrendsSEC Filings Lakewood-Amedex Biotherapeutics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Lakewood-Amedex Biotherapeutics (LABT). Over the past two years, Lakewood-Amedex Biotherapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Nu-3. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Nu-3 FDA Regulatory Events Nu-3 is a drug developed by Lakewood-Amedex Biotherapeutics for the following indication: for the treatment of patients with mildly infected diabetic foot ulcers (iDFU). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Dose Update - September 24,2026Dose Update Phase 2aDrug: Nu-3Announced Date: September 24, 2026Indication: for the treatment of patients with mildly infected diabetic foot ulcers (iDFU).Announcement- Lakewood-Amedex Biotherapeutics Inc. announced that the first patient has been dosed in its Phase 2a clinical trial evaluating Nu-3 for the treatment of patients with mildly infected diabetic foot ulcers (iDFU).Read Announcement Lakewood-Amedex Biotherapeutics FDA Events - Frequently Asked Questions Has Lakewood-Amedex Biotherapeutics received FDA approval? As of now, Lakewood-Amedex Biotherapeutics (LABT) has not received any FDA approvals for its therapy in the last two years. What drugs has Lakewood-Amedex Biotherapeutics submitted to the FDA? In the past two years, Lakewood-Amedex Biotherapeutics (LABT) has reported FDA regulatory activity for Nu-3. What is the most recent FDA event for Lakewood-Amedex Biotherapeutics? The most recent FDA-related event for Lakewood-Amedex Biotherapeutics occurred on September 24, 2026, involving Nu-3. The update was categorized as "Dose Update," with the company reporting: "- Lakewood-Amedex Biotherapeutics Inc. announced that the first patient has been dosed in its Phase 2a clinical trial evaluating Nu-3 for the treatment of patients with mildly infected diabetic foot ulcers (iDFU)." What conditions do Lakewood-Amedex Biotherapeutics' current drugs treat? Currently, Lakewood-Amedex Biotherapeutics has one therapy (Nu-3) targeting the following condition: for the treatment of patients with mildly infected diabetic foot ulcers (iDFU).. 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FDA EventsAC Immune FDA EventsArcturus Therapeutics FDA EventsArtelo Biosciences FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies BioCardia FDA Events Passage Bio FDA Events Applied Therapeutics FDA Events BioVie FDA Events Tempest Therapeutics FDA Events Vyome FDA Events GT Biopharma FDA Events NeuroSense Therapeutics FDA Events Enlivex Therapeutics FDA Events BioLineRx FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:LABT last updated on 9/24/2026 by MarketBeat.com Staff. 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Dose Update - September 24,2026Dose Update Phase 2aDrug: Nu-3Announced Date: September 24, 2026Indication: for the treatment of patients with mildly infected diabetic foot ulcers (iDFU).Announcement- Lakewood-Amedex Biotherapeutics Inc. announced that the first patient has been dosed in its Phase 2a clinical trial evaluating Nu-3 for the treatment of patients with mildly infected diabetic foot ulcers (iDFU).Read Announcement
